The Changing Guidelines for the Review of Genetic Patents

The Patent and Trademark Office has changed its rules several times over the last decade to cope with a torrent of patent applications for human genes and gene fragments. Officials suggest that the latest changes should fix most problems and be the last that are needed.

That seems unlikely.

The office issued two proposals shortly before Christmas, one that would boost the standard that applicants must meet to prove their gene discoveries are “useful,” and the other that could affect the scope of patents on genetic material.

Both would take the form of guidelines, rather than outright rules, for examiners to follow in reviewing patent applications. But patent experts say they would have the same practical effect. The public has until March 22 to comment before the proposals, which patent examiners are already following, take full effect.

The first proposal would require that patent applicants demonstrate a “specific,” “substantial” and “credible” utility for their discoveries. As of now, only a “credible” utility is required.

Critics say that while the new standard would be an improvement, it would not address their fundamental opposition to any patenting of the genetic code. While they accept that uses of the code can be patented, they want the code itself to be openly available as a research tool.

The second proposed rule deals with the nettlesome question of scope. At issue is how much of a stretch of code applicants can claim on either side of the immediate piece of genetic material that they are seeking to patent.

How the rule works will not be clear until the patent office issues examples in the next few weeks.